US FDA 1572 - completion for ex-US sites
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Anon
30/01/2020 14:31
Is anyone aware of a regulation / GUI / Reflection Paper that suggests ex-US sites are not required to sign the US FDA 1572 . Thank you.
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Colin Wilsher
30/01/2020 15:23
Yes. The FDA Q& A document on 1572. Google it. Also there are lots of discussion here on RQA discussion forum on this topic
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Colin Wilsher
30/01/2020 15:30
Yes. The FDA Q& A document on 1572. Google it. Also there are lots of discussion here on RQA discussion forum on this topic
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Anon
30/01/2020 17:30
Thank you, Colin. Will take a look right away.
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Aldwin Aldana
27/02/2020 18:23
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Aldwin Aldana
27/02/2020 18:52
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Colin Wilsher
27/02/2020 19:51
Fantastic information. Thanks. In fact the FDA has been sending messages since 2003 stating that it is easier for them if non-US sites are outside of the IND. And its cheaper and less hassle for the sponsor >> PS> Did you know that that the RQA GCP Committee is looking for more volunteers?
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Aldwin Aldana
04/03/2020 16:27
I would like to learn more about the volunteer opportunities.
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Colin Wilsher
04/03/2020 16:34
Go on RQA website and contact
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Alice
14/12/2020 09:57
Where I can find the a full list of EU Competent Authority who are refusing to allow
investigators at sites in their country to sign Form FDA 1572?
The list on the EFPIA CDEG position paper is not complete: " (e.g. in Belgium, Germany, Denmark, Sweden, Norway)"
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